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Intraosseous Basivertebral Nerve Ablation for Treatment of Chronic Low Back Pain (CLBP)

Primary Purpose

Chronic Low Back Pain

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intracept System Ablation
Sponsored by
Relievant Medsystems, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Low Back Pain

Eligibility Criteria

25 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Skeletally mature subjects age 25-70 years, inclusive
  • Chronic lower back pain for at least six months
  • Failure to respond to at least six months of non-operative conservative management
  • Oswestry Disability Index (ODI) at time of evaluation of at least 30 points
  • Modic changes (Type 1 or 2) in at least one vertebral endplate, at one or more levels from L3 to S1

Exclusion Criteria:

  • Radicular pain by history or evidence of pain neurological deficit within the past one year.
  • Previous surgery performed on the lumbar spine
  • Current or history of symptomatic spinal stenosis
  • Current or history of osteoporotic or tumor-related vertebral body compression fracture
  • Current or history of vertebral cancer or spinal metastasis
  • Current or history of spinal infection
  • Metabolic bone disease
  • BMI greater or equal to 40
  • Any radiographic evidence of other important back pathology
  • MRI evidence of Modic changes, Type 1 or 2 at greater than 3 vertebral bodies or at non-consecutive levels, or at vertebral bodies other than L3 to S1
  • Any back pathology related to trauma, evidence of vertebral compression fracture or other spinal pathology that could affect assessment of response to back pain
  • Subjects who are bed bound
  • Demonstrates 3 or more Waddell's signs of Inorganic Behavior
  • Any evidence of current systemic infection

Sites / Locations

  • Texas Back Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intracept System Ablation

Arm Description

Outcomes

Primary Outcome Measures

Oswestry Disability Index (ODI)
Mean change in Oswestry Disability Index Score from baseline to 3 months post-treatment. Scale is measured from 0 to 100, better to worse respectively.

Secondary Outcome Measures

Visual Analog Scale (VAS)
Mean change in Visual Analog Scale (VAS) pain score from baseline to 3, 6, 9 and 12 months post-treatment. Scale is measured from 0 to 10, better to worse respectively.
Oswestry Disability Index (ODI)
Mean change in Oswestry Disability Index (ODI) score from baseline to 6, 9 and 12 months post-treatment. Scale is measured from 0 to 100, better to worse respectively.

Full Information

First Posted
August 31, 2018
Last Updated
August 13, 2019
Sponsor
Relievant Medsystems, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03658018
Brief Title
Intraosseous Basivertebral Nerve Ablation for Treatment of Chronic Low Back Pain
Acronym
CLBP
Official Title
A Prospective, Open-Label, Single-Arm, Single-Center Study of Intraosseous Basivertebral Nerve Ablation for the Treatment of Chronic Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Withdrawn
Why Stopped
No Enrollments
Study Start Date
January 2, 2019 (Actual)
Primary Completion Date
July 12, 2019 (Anticipated)
Study Completion Date
July 12, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Relievant Medsystems, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
Objective of study is to evaluate the procedural success rate, clinical effectiveness, and heath-economic profile using the Intercept Intraosseous Nerve Ablation System in adult subjects with chronic low back pain in the post-market setting
Detailed Description
This is a prospective, open-label, single-arm, single-center study. There is no randomization or blinding. Subjects will receive the Intercept System procedure to treat one or two motion segments at L3/L4, L4/L5, or L5/S1 as identified by Modic Type 1 or 2 changes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intracept System Ablation
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Intracept System Ablation
Intervention Description
Radiofrequency ablation using Intracept System
Primary Outcome Measure Information:
Title
Oswestry Disability Index (ODI)
Description
Mean change in Oswestry Disability Index Score from baseline to 3 months post-treatment. Scale is measured from 0 to 100, better to worse respectively.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Visual Analog Scale (VAS)
Description
Mean change in Visual Analog Scale (VAS) pain score from baseline to 3, 6, 9 and 12 months post-treatment. Scale is measured from 0 to 10, better to worse respectively.
Time Frame
3, 6, 9, and 12 months
Title
Oswestry Disability Index (ODI)
Description
Mean change in Oswestry Disability Index (ODI) score from baseline to 6, 9 and 12 months post-treatment. Scale is measured from 0 to 100, better to worse respectively.
Time Frame
6, 9, and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Skeletally mature subjects age 25-70 years, inclusive Chronic lower back pain for at least six months Failure to respond to at least six months of non-operative conservative management Oswestry Disability Index (ODI) at time of evaluation of at least 30 points Modic changes (Type 1 or 2) in at least one vertebral endplate, at one or more levels from L3 to S1 Exclusion Criteria: Radicular pain by history or evidence of pain neurological deficit within the past one year. Previous surgery performed on the lumbar spine Current or history of symptomatic spinal stenosis Current or history of osteoporotic or tumor-related vertebral body compression fracture Current or history of vertebral cancer or spinal metastasis Current or history of spinal infection Metabolic bone disease BMI greater or equal to 40 Any radiographic evidence of other important back pathology MRI evidence of Modic changes, Type 1 or 2 at greater than 3 vertebral bodies or at non-consecutive levels, or at vertebral bodies other than L3 to S1 Any back pathology related to trauma, evidence of vertebral compression fracture or other spinal pathology that could affect assessment of response to back pain Subjects who are bed bound Demonstrates 3 or more Waddell's signs of Inorganic Behavior Any evidence of current systemic infection
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Isador Lieberman, MD
Organizational Affiliation
Texas Back Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Texas Back Institute
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Time Frame
At the completion of trial
IPD Sharing URL
http://clbpstudy.com

Learn more about this trial

Intraosseous Basivertebral Nerve Ablation for Treatment of Chronic Low Back Pain

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